Application 215069
- Type
- ANDA
- Sponsor
- SCIEGEN PHARMS INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | LEVETIRACETAM | LEVETIRACETAM | TABLET;ORAL | 750MG | No | No |
| 002 | LEVETIRACETAM | LEVETIRACETAM | TABLET;ORAL | 1GM | No | No |
| 003 | LEVETIRACETAM | LEVETIRACETAM | TABLET;ORAL | 250MG | No | No |
| 004 | LEVETIRACETAM | LEVETIRACETAM | TABLET;ORAL | 500MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50228-470 | Levetiracetam | Levetiracetam | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-470 | Levetiracetam | Levetiracetam | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-471 | Levetiracetam | Levetiracetam | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-471 | Levetiracetam | Levetiracetam | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-472 | Levetiracetam | Levetiracetam | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-472 | Levetiracetam | Levetiracetam | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-472 | Levetiracetam | Levetiracetam | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-473 | Levetiracetam | Levetiracetam | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-473 | Levetiracetam | Levetiracetam | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-473 | Levetiracetam | Levetiracetam | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 68085 | ORIG | 2021-07-14 |
| 68084 | ORIG | 2021-07-14 |